Enforcement Comeback? FDA Predicts 1,767% Increase In US Inspections In FY ’22, Matching Pre-Pandemic Levels
An FDA budget request released on 28 May estimates that domestic GMP inspections of US device makers will increase from a mere 75 in the current 2021 fiscal year to 1,400 in FY 2022. It also asks for an increase of $18.8m to pay for inspections of all commodities the agency oversees.
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A 5 May report from the US FDA says that even under the most favorable COVID-19 conditions the agency’s inspections of makers of medical and tobacco products will likely be cut in half this fiscal year. The FDA also announced it will launch an agency-wide Inspectional Affairs Council to “plan and coordinate inspectional activities.”
A document from the US FDA obtained by Medtech Insight advises medical device manufacturers on how a voluntary Remote Regulatory Assessment will unfold. RRAs are being conducted by the agency in lieu of on-site facility inspections because of the COVID-19 pandemic.
COVID-19: US FDA’s Hahn Slams The Brakes On Domestic Inspections ‘For The Health And Well-Being Of Our Staff’
A little more than a month after it put the kibosh on conducting facility inspections in China, the agency announced late on 18 March that it was suspending routine surveillance audits in the US, too.